OSTEOMED IB DRILL

Handpiece, Air-powered, Dental

OSTEOMED CORP.

The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Ib Drill.

Pre-market Notification Details

Device IDK911937
510k NumberK911937
Device Name:OSTEOMED IB DRILL
ClassificationHandpiece, Air-powered, Dental
Applicant OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale,  CA  91202
ContactRich A Buss
CorrespondentRich A Buss
OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale,  CA  91202
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-01
Decision Date1991-06-10

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